TAMPA, Fla. — Pfizer Inc. is expected to turn over its clinical study that researched the coronavirus vaccine in kids to the Food and Drug Administration, the Associated Press reports.
The FDA Vaccine Chief, Dr. Peter Marks, said he is hopeful that vaccinations for kids ages 5 to 11 years old will be underway by the end of the year.
Sunday, the former FDA Commissioner Dr. Scott Gottlieb predicted that the agency will authorize Pfizer's COVID-19 vaccine for emergency use in children by the end of October, CBS News reports. Gottlieb now serves on Pfizer's board of directors.
During an interview with "Face the Nation," Gottlieb said Pfizer will have the study data before the end of September, "so they'll file very quickly with the FDA." Once it's filed, the FDA said it will take a matter of weeks, not months, to determine if it will authorize the vaccine for kids ages 5 to 11.
Gottlieb said he interprets that to be between four and six weeks before the FDA makes the final decision. If given the green light, that could mean children will be eligible for a first Pfizer vaccine dose before Halloween.
Local health experts who have been anticipating the FDA's approval for vaccines for younger children said this could help slow the spread of the virus.
"As a parent of a child who is 8, I will be standing in that line to have my 8-year-old vaccinated," said Dr. Jill Roberts, College of Public Health, Global and Planetary Health at University of South Florida.
Pediatric cases have spiked across the country in recent weeks with more than 750,000 COVID-19 cases in children from early August to early September.
Roberts said mutating variants which evade vaccine potency remain a threat to ending the pandemic.
"We really have to stop it or we're going to keep having conversations about one variant after another," Dr. Roberts said.
Pfizer is expected to seek vaccine approval for kids as young as 5 within the weeks and make results of its study available
"Pfizer has said that they're going to have data before the end of September and they could be ready to file within days of having that data," Dr. Gottlieb said.
There were concerns that more data on how the vaccines affect young children should be collected, but medical experts say they are not getting reports of problems with older children to support waiting longer to roll out the vaccine.
"The data that we have so far does not show any adverse effects in older kids and I really don't think that there's any reason to expect their physiology or anything like that would be any different at this point," said Roberts.
While she cautioned about vaccinating children younger than 5, Robert's said expanding the vaccine eligibility to younger children in the 5 to 11 age group is a game changer as we head towards the holidays, but not on time for Halloween "Trick or Treat."
"We may be really looking at a Thanksgiving holiday that kids can engage safely with family members that are high-risk and Christmas is going to open up all different kinds of possibilities," she said.
Dr. Robert said children can still have a safe Halloween if they mask up, social distance and use hand sanitizer frequently. She also urged that as parents wait for the COVID-19 vaccine approval for younger children, they should go ahead and start getting them their flu shots.